Product code KMT
- Device name
- Tray, Fluoride, Disposable
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6870
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031809 | PERIO PROTECT TRAY | Perio Protect, LLC | 2004-01-23 |
| K904914 | DENTAL VACUUM INJECTION TRAY | The Lebanon Vac-Tray Corp. | 1990-12-17 |
| K871784 | TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI | Colgate-Hoyt Laboratories | 1987-05-27 |
| K853882 | SUPER SLICK | Tang Products | 1985-11-18 |
| K820104 | NUPRO* GEL TRAY | Johnson & Johnson Professionals, Inc. | 1982-02-23 |
| K811154 | HOYT ECONO-TRAY | Hoyt Laboratories | 1981-05-13 |
| K780712 | KERR DISCOVERY DISPOSABLE FLUORIDE TRAY | Kerr Corporation (Danbury) | 1978-05-17 |
| K770064 | FLUORIDE GEL DISPOSABLE TRAY | Lorvic Corp. | 1977-01-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10371347010951 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-03-08 |
| 10371347010968 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-03-08 |
| 10371347010975 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-03-08 |
| 10371347010982 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-03-08 |
| 10371347010999 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-03-08 |
| 10371347011002 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-03-08 |
| 10371347010944 | Advance Dental Products | The Atlanta Dental Supply Company | 2023-03-08 |
| D0031300831 | NUPRO® | Dentsply Professional | 2022-12-03 |
| D0031300821 | NUPRO® | Dentsply Professional | 2022-12-03 |
| D0031300811 | NUPRO® | Dentsply Professional | 2022-12-03 |
| D0031300801 | NUPRO® | Dentsply Professional | 2022-12-03 |
| 00302732950692 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 00302732950685 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 00302732950678 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 00302732950661 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 00302732950654 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 00302732950647 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 10732224001330 | Zap™ Dual Arch Fluoride Gel Trays | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224001347 | Zap™ Dual Arch Fluoride Gel Trays | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224001354 | Zap™ Dual Arch Fluoride Gel Trays | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10686864047756 | MEDICOM DENTICARE PRO-TRAY | AMD Medicom Inc | 2019-01-17 |
| 10686864047749 | MEDICOM DENTICARE PRO-TRAY | AMD Medicom Inc | 2019-01-15 |
| 10686864047732 | MEDICOM DENTICARE PRO-TRAY | AMD Medicom Inc | 2019-01-15 |
| 10686864047725 | MEDICOM DENTICARE PRO-TRAY | AMD Medicom Inc | 2019-01-15 |
| 10686864047718 | MEDICOM DENTICARE PRO-TRAY | AMD Medicom Inc | 2019-01-15 |
| 10686864047701 | MEDICOM DENTICARE PRO-TRAY | AMD Medicom Inc | 2019-01-15 |
| 10841396117289 | Discovery Tray | KERR CORPORATION | 2016-08-31 |
| 10841396117272 | Discovery Tray | KERR CORPORATION | 2016-08-31 |
| 10841396117265 | Discovery Tray | KERR CORPORATION | 2016-08-31 |
| 10841396117258 | Discovery Tray | KERR CORPORATION | 2016-08-31 |